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Completed

NCT Number: NCT00278980

Effect of C-Peptide on Diabetic Peripheral Neuropathy

The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Diabetic Polyneuropathy Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital Solna

Stockholm, Stockholm County, SE-171 76, Sweden

About this study

It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who have a duration of type 1 diabetes of more than 5 yrs
  • Subjects who are C-peptide deficient
  • Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
  • Subjects who have measurable action potential in the sural nerves
  • Subjects who have reduced nerve conduction velocity in the sural nerves

Exclusion criteria

  • Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
  • Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
  • Subjects who are transplanted (islet cell, kidney or pancreas)

Treatment and study plan

C-peptide

Drug

Primary outcomes

  1. Change in sensory nerve conduction velocity from baseline to 6 mo of treatment

Secondary outcomes

  1. - Change in quantitative sensory tests and

  2. neurological impairment assessment from baseline to 6 mo of treatment

  3. - Safety and tolerability of C-peptide

Sponsors and collaborators

Lead sponsor

Creative Peptides Sweden Inc.

Industry

Registry information

Official study title

Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups

Important dates

Study start
2003
Study completion
2004
First posted
Jan 19, 2006
Registry last updated
Jan 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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